Is Postoperative Quality of Recovery After Unilateral Nephrectomy Related to the Type of Anesthesia and Analgesia?
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Visual analog scale of quality of recovery (QoR)
研究概览
简要总结
Different modality of anesthesia and analgesia could influence a postoperative quality of recovery (QoR). This study is exploring early QoR after unilateral nephrectomy in the two groups of anesthesia. The first group had a light general anesthesia with thoracic epidural anesthesia and postoperative epidural analgesia with morphine and ropivacaine. The second group had general anesthesia and a continuous postoperative analgesia with tramadol. The postoperative QoR was evaluated 24 hours after surgery.
详细描述
All participants were premedicated with diazepam 5 mg 12 hours and 1 hour before surgery. Thromboprophylaxis ( 4,000 - 6000 IU) depending on the body weight was given at least 12 hours before surgery. All participants were warmed to prevent unintended hypothermia. Participants were allocated by permuted-block randomisation into one of two groups: general anesthesia group and epidural anesthesia. The randomisation list was obtained from R program version 3.5.3. The group allocations were contained in a closed envelope that were opened before surgery after the completed enrollment procedure. All patients and infusions were wormed to prevent unintended hypothermia. Induction of general anesthesia was with midazolam 2.5 mg, fentanyl 100 μg, propofol 1-2 mg/kg and vecuronium 0.1 mg/kg.
Balanced crystalloid fluids were used to treat hypovolemia. Additionally, 6% Hydroxyethyl starch was used before blood transfusion products to treat profound hypovolemia.
Blood transfusions were given according to clinical situation. Bradycardia was treated with atropine. Hypotension was treated with ephedrine boluses. Anti-inflammatory drug metamizole (dipyrone) 2.5 g was given intravenously before the end of the surgery and after 12 hours after the surgery. Neostigmine 2.5 mg with atropine 1 mg was used for the reversal of the effects of non-depolarizing neuromuscular blocking agents after surgery. Participants were placed for one day in a urology high care unit provided with constant and vigilant nurse care.
Crystalloid infusions were used for maintaining diuresis. Gastroprotection was done with pantoprazole 40 mg. Metoclopramid 10 mg was given for postoperative nausea and vomiting (PONV).
The postoperative QoR was evaluated with three QoR scales. Scales for pain, anxiety and PONV were also examined. The 36-Item Short Form Survey (SF-36) questionnaire evaluated quality of life one month before and one month after surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Elective radical nephrectomy
- •American Society of Anesthesiologists (ASA) physical status classification system: I, II, III
排除标准
- •Acute psychosis
- •Emergent surgery
- •Hospitalisation in Intensive care unit
- •American Society of Anesthesiologists (ASA) physical status classification system: IV
- •Reoperations
- •Muscular diseases
- •Montreal cognitive test <24 points
- •Contraindications for epidural anesthesia
研究组 & 干预措施
Epidural anesthesia and analgesia
Epidural catheter insertion: Th 9 - Th 10 or Th 10 - Th 11 using the midline approach.
Safety of the epidural catheter was confirmed with lidocaine 60 mg. Epidural loading dose was given according to our classification (3,4,5 or 6 ml).
Postoperative period in urology high care unit. Epidural analgesia ropivacaine/morphine was administered by a urologist according to our classification (2x2 ml, 2x3 ml and 3x3 ml).
干预措施: Postoperative epidural analgesia (Procedure)
Epidural anesthesia and analgesia
Epidural catheter insertion: Th 9 - Th 10 or Th 10 - Th 11 using the midline approach.
Safety of the epidural catheter was confirmed with lidocaine 60 mg. Epidural loading dose was given according to our classification (3,4,5 or 6 ml).
Postoperative period in urology high care unit. Epidural analgesia ropivacaine/morphine was administered by a urologist according to our classification (2x2 ml, 2x3 ml and 3x3 ml).
干预措施: Epidural anesthesia with light general anesthesia (Procedure)
Balanced general anesthesia and tramadol analgesia
Postoperative period in urology high care unit.
干预措施: General anesthesia (Procedure)
Balanced general anesthesia and tramadol analgesia
Postoperative period in urology high care unit.
干预措施: Continuous intravenous analgesia (Drug)
结局指标
主要结局
Visual analog scale of quality of recovery (QoR)
时间窗: 24 hours after surgery
Patient rated visual analog scale is a simple scale for rating the quality of recovery by placing "X" on the line. Poor recovery is on the left side of the line. Under the end of the left line is an explanation of poor recovery: in severe pain, nausea \& vomiting, confused, immobilized, unable to eat and unable to communicate. Excellent recovery is on the right side of the line. Under the end of the line is a written explanation: without any pain, comfortable, alert, active, enjoying food and communicating freely.
Quality of recovery 40 (QoR-40)
时间窗: 24 hours after surgery
The QoR-40 measures five related dimensions of quality of recovery: emotional state (8 items), physical comfort (12 items), physical independence (5 items), psychological support (7 items) and pain (7 items). Each item is rated on a 5 point Likert scale. Minimal possible score is 40 and maximal possible score is 200.
Quality of recovery 15 (QoR-15)
时间窗: 24 hours after surgery
Quality of recovery (QoR-15) is a short version of QoR - 40 questionnaire. The QoR-15 questionnaire has 15 items scaled from 0 to 10. Minimum score is 0, and maximum 150. It is shorter, user friendly and less time consuming then extensive QoR-40 questionnaire.
次要结局
- Visual anxiety scale with faces(24 hours after surgery)
- The short form health survey version one (SF-36:I)(24 hours after surgery and one month after surgery)
- Simplified postoperative nausea and vomiting (PONV) impact scale(24 hours after surgery)
- Global visual analog and numeric scale of nausea intensity(24 hours after surgery)
- Visual analog scale of pain- at rest and during coughing and straining(24 hours after surgery)
- Visual analog scale of anxiety(24 hours after surgery)
- Numerical anxiety scale(24 hours after surgery)
- Numerical pain scale - at rest and during coughing and straining(24 hours after surgery)
- Visual pain scale with faces- at rest and during coughing and straining(24 hours after surgery)
研究者
Ruben Kovac
Principal Investigator
University Hospital of Split